NEW YORK, December 18, 2025 — Leads & Copy — Tilray Medical, a division of Tilray Brands, Inc., confirmed its strategic framework to advance its U.S. medical cannabis operations following federal cannabis rescheduling and related regulatory developments. In conjunction with these regulatory changes, Tilray announced the formation of Tilray Medical USA, Inc., further strengthening its commitment to leading medical cannabis innovation and growth.
Irwin D. Simon, Chairman and Chief Executive Officer of Tilray Brands, stated the company supports President Trump’s decision to reschedule cannabis as a constructive and necessary evolution of U.S. federal policy.
Simon said this action aligns regulation with a vast body of scientific and medical data supporting cannabis medical use and safety, economic progress, and a healthcare-focused framework, while creating a more credible foundation for medical cannabis research, clinical development, and regulatory clarity. He added that it also signals a future shaped by innovation, responsible oversight, and evidence-based policy and that Tilray believes this landmark decision is a significant catalyst for positive change within the health, wellness, and business communities across the U.S. and a critical, incremental step toward descheduling and comprehensive regulation.
Simon said that Tilray has dedicated years to developing the necessary infrastructure, scientific knowledge, and regulatory skills to operate responsibly in federally legal medical cannabis markets. As U.S. policies evolve, he said the company is prepared to engage thoughtfully and in full compliance – just as it has led in over 20 international medical cannabis markets. Simon added that Tilray believes it is well-positioned to take the lead as it has the experienced team in place and remains committed to supporting the development and growth of a research-focused federal medical cannabis industry in the U.S.
The direct and indirect impacts of federal cannabis rescheduling have the potential to expand access to medical research and clinical trials, improve standardization, and support the development of evidence-based cannabis therapies – key prerequisites for an integrated state-federal medical cannabis framework within the U.S. healthcare system.
Tilray Medical has built its leadership in federally regulated medical cannabis markets globally by working closely with regulators, physicians, hospitals, and research institutions to uphold the highest standards of quality, compliance, and patient safety. Tilray currently offers more than 200 registered medical cannabis products across international markets for therapeutic use, has served over 500,000 registered patients globally, and has participated in more than 15 medical cannabis studies and clinical trials in partnership with leading hospitals and physicians studying cannabis for various conditions including pediatric epilepsy, cancer-induced nausea, PTSD, pain, anxiety, essential tremors, alcohol use disorder, fibromyalgia, glioblastoma, and cannabinoids and driving performance.
With an established global footprint, mature compliance infrastructure, and deep scientific and regulatory expertise, Tilray Medical plans to adapt swiftly to regulatory developments while maintaining the highest standards of governance, patient safety, and operational integrity. The Company intends to strategically expand collaborations with healthcare operators and medical professionals, ensuring all partnerships are aligned with emerging regulatory medical guidelines. As part of its forward-looking plan, Tilray Medical USA aims to introduce medical-grade cannabis products in targeted therapeutic formats, drawing on real-world data and physician-driven insights accumulated from its international operations.
About Tilray Brands
Tilray Brands, Inc. is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.
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Source: Tilray
